LUNESTA- eszopiclone tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

ESZOPICLONE

Composition:

ESZOPICLONE 3 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LUNESTA ® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). LUNESTA is contraindicated in patients who have experienced complex sleep behaviors after taking LUNESTA LUNESTA is contraindicated in patients who have experienced complex sleep behaviors after taking LUNESTA [see Warnings and Precautions ( 5.1)]. LUNESTA is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema . LUNESTA is contraindicated in patients w

Product summary:

LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side, and are supplied as: NDC 55289-014-30 bottle of 30 tablets Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

LUNESTA- eszopiclone tablet, coated
PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
LUNESTA ® (lū'-nes''-tă) Tablets, Coated C-IV
(eszopiclone)
Read the Medication Guide that comes with LUNESTA before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
doctor about your medical condition or treatment.
What is the most important information I should know about LUNESTA?
•
Do not take more LUNESTA than prescribed.
•
Do not take LUNESTA unless you are able to stay in bed a full night (7
to 8 hours) before you must
be active again.
•
Take LUNESTA right before you get in bed, not sooner.
LUNESTA may cause serious side effects, including:
Complex sleep behaviors that have caused serious injury and death.
After taking LUNESTA, you may get up
out of bed while not being fully awake and do an activity that you do
not know you are doing (complex sleep
behaviors). The next morning, you may not remember that you did
anything during the night. These activities
may occur with LUNESTA whether or not you drink alcohol or take other
medicines that make you sleepy.
Reported activities and behaviors include:
•
doing activities when you are asleep like:
•
making and eating food
•
talking on the phone
•
having sex
•
driving a car ("sleep-driving")
•
sleep walking
Stop taking LUNESTA and call your healthcare provider right away if
you find out that you have done any
of the above activities after taking LUNESTA.
The morning after you take LUNESTA your ability to drive safely and
think clearly may be decreased. You
also may experience sleepiness during the day.
Do not take LUNESTA if you:
•
have ever experienced a complex sleep behavior (such as driving a car,
making and eating food,
talking on the phone or having sex while not fully awake) after taking
LUNESTA
•
drank alcohol that evening or before bed
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines. Your
doctor

Summary of Product characteristics

LUNESTA- ESZOPICLONE TABLET, COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LUNESTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LUNESTA.
LUNESTA (ESZOPICLONE) TABLETS, FOR ORAL USE, C
INITIAL U.S. APPROVAL: 2004
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF LUNESTA.
SOME OF THESE
EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE
LUNESTA
IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR ( 4,
5.1).
RECENT MAJOR CHANGES
Boxed Warning
08/2019
Contraindications ( 4)
08/2019
Warnings and Precautions, Complex Sleep Behaviors ( 5.1)
08/2019
Warnings and Precautions, CNS Depressant Effects and Next-Day
Impairment ( 5.2)
12/2018
INDICATIONS AND USAGE
LUNESTA is indicated for the treatment of insomnia. LUNESTA has been
shown to decrease sleep latency
and improve sleep maintenance ( 1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient ( 2)
Recommended initial dose is 1 mg, immediately before bedtime, with at
least 7-8 hours remaining
before the planned time of awakening. May increase dose if clinically
indicated, to a maximum of 3 mg (
2.1)
Geriatric or debilitated patients: Dose should not exceed 2 mg ( 2.2)
Patients with severe hepatic impairment, or taking potent CYP3A4
inhibitors: Dose should not exceed 2
mg ( 2.3)
Do not take with or immediately after a meal ( 2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg ( 3)
CONTRAINDICATIONS
Patients who have experienced complex sleep behaviors after taking
LUNESTA ( 4)
Known hypersensitivity to eszopiclone ( 4)
WARNINGS AND PRECAUTIONS
_CNS Depressant Effects:_ Impaired alertness and motor coordination,
including risk of morning
impairment. Risk increases with dose and use with other CNS
depressants and al